FDA 510(k) Application Details - K963365

Device Classification Name Device, Intravascular Catheter Securement

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510(K) Number K963365
Device Name Device, Intravascular Catheter Securement
Applicant BYRD MEDICAL DEVICES, INC.
111 CENTER PARK DR., SUITE 200
KNOXVILLE, TN 37922 US
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Contact TIM BYRD
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Regulation Number 880.5210

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Classification Product Code KMK
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Date Received 08/27/1996
Decision Date 10/11/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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